Senior QA Specialist

Senior QA Specialist

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. 2025, Eurofins generated total revenues of EUR € 7.296 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

• Lead and perform deviation and investigation writing/review, including thorough root cause analysis and CAPA development/effectiveness checks
• Review and approve quality agreements and ensure alignment with regulatory and client requirements
• Host and support external audits, including regulatory agency inspections and client audits
• Conduct internal audits, walkthrough inspections, and ensure audit readiness across laboratory operations
• Perform and support risk assessments to proactively identify and mitigate quality risks
• Drive data integrity compliance initiatives, ensuring adherence to ALCOA+ principles
• Manage and support change control processes, ensuring impact assessments and compliance with procedures
• Review and approve SOPs, analytical methods, protocols, and reports
• Release and ensure accuracy of analytical reports
• Contribute to monthly and quarterly quality metrics reporting
• Identify and implement continuous improvement opportunities within QA and laboratory functions
• Partner cross-functionally with laboratory staff, clients, and leadership to ensure quality objectives are met
• Maintain a strong commitment to safe, compliant, and efficient operations

Qualifications

• Bachelor's degree in Chemistry, Biology, Biochemistry, or related scientific discipline
• 4+ years of QA experience within a pharmaceutical or regulated laboratory environment
• Proven experience with: investigations and CAPA management, audit hosting (client and/or regulatory), quality systems (change control, deviations, document control), data integrity principles and compliance expectations
• Strong working knowledge of GxP (GMP/GLP) regulations
• Excellent written and verbal communication skills
• Ability to confidently interact with clients, auditors, and internal stakeholders
• Proficiency in Microsoft Office (Excel, Word, PowerPoint)
• Authorization to work in the U.S. without sponsorship

Additional Information

Position is full time, Monday to Friday, 8AM - 5PM. Candidates currently living within a commutable distance of Portage, MI are encouraged to apply.

Excellent full time benefits including comprehensive medical coverage, dental, and vision options, life and disability insurance, 401(k) with company match, paid vacation and holidays.

Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.